Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of Food and Drug Administration (FDA) Submissions for Orthopedic and Dental Endosseous Implants

Callahan, TJ; Gantenberg, JB; Sands, B E

doi:10.1520/stp25193s

Cited by 28 publications

(16 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…This pertains, for example, to the forced a/ß transition of alloyed titanium at high temperature, i.e., in direct contact with the hot plasma jet. Fourth, plasma spraying results in rather dense coating layers that may be unable to satisfy biomedical requirements calling for pore sizes in excess of the 75 lm that are necessary to guarantee unimpeded ingrowth of bone cells (Ref [32][33][34]. Indeed, deposition of dense, stoichiometric, and highly crystalline hydroxylapatite coating layers is, from a biomedical point of view, frequently ineffective since those coatings tend to be bioinert as they have lost their osseoconductive property that is based on sufficient solubility.…”

Section: Deposition Of Hydroxylapatite Coatings By Plasma Sprayingmentioning

confidence: 99%

Plasma-Sprayed Hydroxylapatite Coatings as Biocompatible Intermediaries Between Inorganic Implant Surfaces and Living Tissue

Heimann¹

2018

J Therm Spray Tech

View full text Add to dashboard Cite

The present contribution discusses critical aspects of the thermal alteration that HAp particles undergo when passing along the extremely hot plasma jet. This heat treatment leads to dehydroxylated phases such as oxyhydroxylapatite/oxyapatite as well as thermal decomposition products such as tri-and tetracalcium phosphates, and quenched phases in the form of amorphous calcium phosphate (ACP) of variable composition. The contribution also includes studying the influence bioinert TiO 2 bond coats have on adhesion, crystallinity, and composition of HAp coatings. Moreover, the question is being addressed whether oxyapatite might exist as a (meta)stable phase or whether its occurrence is merely an ephemeral event. In addition, the article deals with the role that HAp coatings are playing during in vitro interaction with simulated body fluid (SBF) resembling the composition of extracellular fluid (ECF). The biological and biomechanical advantages of using HAp coatings for medical implants as well as salient aspects of their biomineralization and osseointegration will be discussed in some detail. Keywords hydroxylapatite coatings Á NMR spectroscopy Á osseoconductivity Á osseoinductivity Á oxyapatite Á plasma spraying Á Raman spectroscopy

show abstract

Section: Deposition Of Hydroxylapatite Coatings By Plasma Sprayingmentioning

confidence: 99%

Plasma-Sprayed Hydroxylapatite Coatings as Biocompatible Intermediaries Between Inorganic Implant Surfaces and Living Tissue

Heimann¹

2018

J Therm Spray Tech

View full text Add to dashboard Cite

show abstract

“…A C C E P T E D M A N U S C R I P T ACCEPTED MANUSCRIPT 16 To conclude this section, plasma spayed [202][203][204][205][206][207][208][209]. Sometimes, this deposition process is also called thermal printing [210].…”

Section: Plasma Sprayingmentioning

confidence: 99%

Calcium orthophosphate deposits: Preparation, properties and biomedical applications

Dorozhkin¹

2015

Materials Science and Engineering: C

257

140

View full text Add to dashboard Cite

“…After being implanted, calcium orthophosphate coatings, films and layers might be replaced by autologous bone because such coatings, films and layers participate in bone remodeling responses similar to natural bones (Ong and Chan 1999; Onoki and Hashida 2006; Kobayashi et al 2007; Epinette and Geesink 1995; Willmann 1999; Schliephake et al 2006; Kokubo et al 2003; Habibovic et al 2005; Hahn et al 2009). Minimal requirements for HA coatings, films or layers (Table 2) have first been described in 1992 in the Food and Drug Administration (FDA) guidelines (Callahan et al 1994), as well as a little bit later in the ISO standards (1996). Afterwards, the FDA guidelines were updated in 1997 (U.S. FDA 1995), while the ISO standards were updated in (ISO 2000) and (ISO 2008).…”

Section: Introductionmentioning

confidence: 99%

Calcium orthophosphate coatings, films and layers

Dorozhkin¹

2012

Prog Biomater

118

View full text Add to dashboard Cite

In surgical disciplines, where bones have to be repaired, augmented or improved, bone substitutes are essential. Therefore, an interest has dramatically increased in application of synthetic bone grafts. As various interactions among cells, surrounding tissues and implanted biomaterials always occur at the interfaces, the surface properties of the implants are of the paramount importance in determining both the biological response to implants and the material response to the physiological conditions. Hence, a surface engineering is aimed to modify both the biomaterials, themselves, and biological responses through introducing desirable changes to the surface properties of the implants but still maintaining their bulk mechanical properties. To fulfill these requirements, a special class of artificial bone grafts has been introduced in 1976. It is composed of various mechanically stable (therefore, suitable for load bearing applications) biomaterials and/or bio-devices with calcium orthophosphate coatings, films and layers on their surfaces to both improve interactions with the surrounding tissues and provide an adequate bonding to bones. Many production techniques of calcium orthophosphate coatings, films and layers have been already invented and new promising techniques are continuously investigated. These specialized coatings, films and layers used to improve the surface properties of various types of artificial implants are the topic of this review.Electronic supplementary materialThe online version of this article (doi:10.1186/2194-0517-1-1) contains supplementary material, which is available to authorized users.

show abstract

Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of Food and Drug Administration (FDA) Submissions for Orthopedic and Dental Endosseous Implants

Cited by 28 publications

References 0 publications

Plasma-Sprayed Hydroxylapatite Coatings as Biocompatible Intermediaries Between Inorganic Implant Surfaces and Living Tissue

Plasma-Sprayed Hydroxylapatite Coatings as Biocompatible Intermediaries Between Inorganic Implant Surfaces and Living Tissue

Calcium orthophosphate deposits: Preparation, properties and biomedical applications

Calcium orthophosphate coatings, films and layers

Contact Info

Product

Resources

About